Physical Rehabilitation for Older Patients with Acute HFpEF-The REHAB-HFpEF Trial

老年急性 HFpEF 患者的身体康复 - REHAB-HFpEF 试验

• 批准号: 10501900
• 负责人: DALANE W KITZMAN
• 金额: $ 594.4万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-15 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10501900
• 关键词: Accident and Emergency department; Acute; Address; Affect; Age; Attention; Black Populations; Blood specimen; Caregivers; Cessation of life; Clinic Visits; Clinical; Cognition; Data; Dissemination and Implementation; EFRAC; Educational workshop; Elderly; Enrollment; Ensure; Event; Evidence based treatment; Funding; Future; Geography; Guidelines; Health Care Costs; Health system; Heart failure; Hospitalization; Impairment; Institutionalization; Intervention; Leadership; Medical; Medicare claim; Mental Depression; Morbidity - disease rate; Multicenter Trials; National Heart, Lung, and Blood Institute; Not Hispanic or Latino; Outcome; Participant; Pathway interactions; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Phase; Phenotype; Physical Function; Physical Performance; Physical Rehabilitation; Physical activity; Prevalence; Randomized; Recommendation; Reporting; Research Personnel; Resources; Structure; Subgroup; Syndrome; Testing; Time; Underserved Population; Vulnerable Populations; Walking; Woman; adjudicate; attentional control; clinical care; clinical center; cohesion; cost effectiveness; cost estimate; data repository; disability; experience; falls; follow-up; frailty; health care service utilization; health related quality of life; heart preservation; high risk; high risk population; hospital readmission; improved; innovation; intervention effect; intervention program; meter; mortality; multidisciplinary; novel; older patient; older women; phase II trial; physical conditioning; physically handicapped; preservation; primary endpoint; primary outcome; response; secondary endpoint; secondary outcome; single-blind trial; treatment as usual; trend

Acute decompensated heart failure (ADHF) is the leading cause of hospitalization in older persons, and is associated with marked physical disability, poor health-related quality of life (HRQOL), frequent rehospitalizations, loss of independence, high mortality, and enormous health care costs. However, most of the trials testing a wide range of medications and strategies in ADHF have been neutral. In our recently completed NIA-funded phase 2 trial (REHAB-HF), an innovative, early, transitional, tailored, and progressive multi-domain physical rehabilitation intervention produced a large improvement in the primary outcome of Short Physical Performance Battery (+1.5 points) in older patients with ADHF. At baseline, the participants (53%) with HF with preserved ejection fraction (HFpEF), had significantly worse impairments in physical function, frailty, HRQOL, and depression than those with HF with reduced EF. They also appeared to derive greater benefit from the intervention, with ~50% larger effect sizes in physical function, frailty, HRQOL, and depression. Patients with HFpEF also appeared to have much greater reductions in rehospitalizations and death and potential for reduced medical resource use. The finding of potentially greater benefit in HFpEF is noteworthy as HFpEF is highly relevant to older persons and has the most urgent need for new treatments since it is: 1) the most common form of HF, nearly unique to older persons, and disproportionately affects older women and Black persons; 2) increasing in prevalence; 3) accepted as a geriatric syndrome; 4) associated with marked impairments in physical function and HRQOL and high rates of frailty; 5) has high morbidity and mortality which are worsening over time; and 6) has limited evidence-based treatments. The phase 3 REHAB- HFpEF trial will focus on this large, growing, vulnerable, underserved population. The 5-year, randomized, attention-controlled, single-blinded trial will enroll 880 older adults age >60 years with ADHF and HFpEF across 20 geographically dispersed clinical centers. We will test the hypothesis that the innovative REHAB-HF intervention will improve the clinically compelling combined primary endpoint of all-cause rehospitalizations and mortality during 6-month follow-up, the most vulnerable time period following ADHF hospitalization (Aim 1) and the secondary endpoint of prevalence of major mobility disability, a clinically meaningful outcome in trials of older adults, at 6-months (Aim 2). We will also assess the intervention’s impact on HRQOL, frailty, depression, physical activity, and health care costs. Our diverse, cohesive, multi-disciplinary team and experience from the phase 2 trial will ensure efficient and effective execution and dissemination. REHAB-HFpEF directly addresses the key recommendations of several recent NIA and NHLBI sponsored workshops. Its results could improve key outcomes that are meaningful to patients, caregivers, health systems, and payers. The trial has strong potential to change clinical guidelines, reduce health care costs, and influence national coverage decisions for the large, growing, underserved, high-risk population of older patients with acute HFpEF.

急性失代偿性心力衰竭（ADHF）是老年人住院的主要原因， 与明显的身体残疾、健康相关生活质量（HRQOL）差、频繁 再住院、丧失独立性、高死亡率和巨大的医疗保健费用。但大部分 在ADHF中测试广泛的药物和策略的试验是中立的。在我们最近 完成了由国家免疫局资助的2期试验（REHAB-HF），这是一项创新的、早期的、过渡的、量身定制的、渐进的 多领域的物理康复干预在短期的主要结局方面产生了很大的改善， 老年ADHF患者的体能组合（+1.5分）。在基线时，参与者（53%） 射血分数保留的HF（HFpEF）患者的身体功能受损明显更严重， 与EF降低的HF患者相比，他们似乎也得到了更大的 从干预中获益，在身体功能、虚弱、HRQOL和 萧条HFpEF患者的再住院率也明显降低， 死亡和减少医疗资源使用的可能性。HFpEF潜在更大获益的发现是 值得注意的是，HFpEF与老年人高度相关，最迫切需要新的治疗方法 因为它是：1）最常见的HF形式，几乎是老年人独有的，并且不成比例地影响老年人 妇女和黑人; 2）患病率增加; 3）被接受为老年综合征; 4）相关 身体功能和HRQOL明显受损，虚弱率高; 5）发病率高， 随着时间的推移，死亡率不断恶化; 6）循证治疗有限。第三阶段REHAB- HFpEF试验将重点关注这一庞大的、不断增长的、脆弱的、服务不足的人群。5年，随机， 一项注意力控制、单盲试验将招募880名年龄>60岁的老年ADHF和HFpEF患者 分布在20个地理位置分散的临床中心。我们将测试创新的REHAB-HF 干预将改善全因再住院的临床综合主要终点， 6个月随访期间的死亡率，ADHF住院后最脆弱的时间段（目标1）， 次要终点主要活动障碍的患病率，在以下试验中具有临床意义的结局： 老年人，6个月（目标2）。我们还将评估干预对HRQOL、虚弱、抑郁的影响， 体力活动和医疗费用。我们的多元化，凝聚力，多学科的团队和经验， 第二阶段试验将确保切实有效地执行和传播。REHAB-HFpEF直接解决 最近NIA和NHLBI主办的几个研讨会的主要建议。其结果可以改善 对患者、护理人员、卫生系统和付款人有意义的关键结果。审判具有很强的 改变临床指南、降低医疗保健成本和影响国家覆盖率的潜力 为大量的、不断增长的、服务不足的、高风险的老年急性HFpEF患者群体做出决策。